FSUE Moscow Endocrine Plant of the Ministry of Industry and Trade of Russia (hereinafter as the Enterprise) together with Solid Pharma Company will take part in the 21st International Exhibition of Equipment, Raw Materials and Technology for Pharmaceutical Production Pharmtech & Ingredients.
As part of Pharmtech & Ingredients, the Enterprise represents its achievements and opportunities to professional society in the area of development, contract manufacturing and quality control of the medicinal products.
In January 2019, FSUE Moscow Endocrine Plant received confirmation of the competence of the quality control department laboratories in RusAccreditation as per the standard GOST ISO/МEК 17025 (accreditation certificate No. RU.RA.21Н019 dd. 22.01.2019). Laboratory facilities (equipment, clean rooms, storage areas) and highly skilled personnel allow for carrying out physicochemical, microbiological and biological testing of medicinal products according to the accreditation area.
In February of 2019, the European Directorate granted FSUE Moscow Endocrine Plant with the European Union GMP compliance certificate on the line for production of injectable sterile medicinal products No. ZVA/LV/2019/002H dd. 04.02.2019, which increased the export potential of the Enterprise and its attractiveness for potential partners in the sphere of contract manufacturing of the medicinal products. The quality system is maintained throughout the entire life cycle of the product: from the stage of product development to the stage of their sale to the final customer.
From 2016 to 2019, large-scale reconstruction and technical re-equipping of the two facilities with the total area over 3 000 sq. m was performed. Upon the reconstruction, the Enterprise managed to rearrange the output of medicinal products in innovative dosage form - transdermal therapeutic systems, and also to increase the capacity of liquid injectable medicinal products/eye drops in vials up to 40 mln. un. per year, to arrange the production of injectable medicinal products in the form of lyophilisates in glass vials with the capacity of 6.5 mln. un. per year, and in dosage forms that are new for the Enterprise - pre-filled syringes, with the capacity of 30 mln. un. per year.
The Enterprise created two subsidiaries within which a large-scale reconstruction and technical re-equipping investment project has been implemented. After reconstruction, the production of solid dosage forms (tablets and capsules), medicinal products in glass vials, emulsion sterile solutions (vials and ampoules), lyophilized products, transdermal therapeutic systems, and spray solutions will be arranged at Lefortovskiy subsidiary.
At “Pochep” subsidiary, the Enterprise will arrange the production of home-produced active pharmaceutical ingridients using materials of animal and vegetable origin, substances produced by chemical and biotechnological synthesis, and medical products.
For reference:
Pharmtech & Ingredients is one of the largest industry exhibitions held on November 19–22, 2019 at the Moscow Exhibition Centre “Crocus Expo”. The event convenes annually the specialists of pharmaceutical industry and the field of production of nutritional supplements, veterinary products and cosmetics.
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